Cerebrovascular DisordersPhase 4FluoesceinNCT02478346
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
A Phase 4 study testing Fluorescein Sodium in people with Cerebrovascular Disorders and Intracranial Neoplasms, run by AdventHealth at 1 site in United States.
Trial summary
This study focuses on implementing Yellow 560 for the direct intraoperative visualization of Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop better treatment protocols, and improve the prognosis of a wide array of neurosurgical diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Disorders, Intracranial Neoplasms
- What is being tested?
- Fluorescein Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18)
- Diagnosed by preoperative imaging modalities to have a brain tumor (including metastatic brain tumors) or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.
- The patient is determined by a board certified neurosurgeon to have a tumor or vascular lesion that would take up fluorescein
- Patient or legally authorized representative provides written informed consent to enroll in this study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Florida Hospital
Orlando, Florida, 32804
About this study
This study focuses on implementing Yellow 560 for the direct intraoperative visualization of Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop better treatment protocols, and improve the prognosis of a wide array of neurosurgical diseases. More specifically, for the patients who are undergoing surgical intervention for the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or in general residual lesion which must be corrected.
Read the detailed description
The research design is a prospective clinical study. All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). Surgery will continue with the aid of the Yellow 560 microscope with a minimum delay of 10 minutes after injection to reduce the amount of leakage of Fluorescein Sodium into the surrounding tissue.
Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
No other additional neurosurgical instruments will be used. Patients will be treated post-operatively with conventional adjunctive therapies and imaging as deemed necessary by the attending neurosurgeon for the evaluation of extent of surgery. Follow-up data (including post-operative images assessing outcomes and complications) will be collected on all patients on standard post-operative visits. Intra-operative films or recordings and all patient data may be saved and used according to HIPAA allowances.
- Conditions
- Cerebrovascular Disorders, Intracranial Neoplasms
- Being tested
- Fluorescein Sodium
- Medical subject headings
- Cerebrovascular Disorders, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescein SodiumDrug
Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Experimental | All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). Receives: Drug: Fluorescein Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intracerebral lesion
The main outcome measure of the study would be a comparison between patient pre-operative and post-operative images to evaluate the potential utility of using Fluorescein Sodium and the Yellow 560 microscope to aid in the treatment of intracranial tumors and vascular lesions.
Measured: Particpants will be followed from enrollment into study which include atleast to 2 images and any other image done up to 1 year of scheudled follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Gandhi, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478346
- Sponsor's protocol ID
- 684812
- Acronym
- Fluoescein
- Status last verified
- Feb 2017
- First submitted
- 27 May 2015
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
1. Ciardella AP, Kaufman SR, Yannuzzi LA. The use of fluorescein angiography in acquired macular diseases. In: Tasman W, Jaeger EA, eds. Foundations of Clinical Ophthalmology. 15th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2009:chap 113F.
2. Dithmar, Stefan, Holz, Frank G. Fluorescence Angiography in Ophthalmology. 2008, X, 224 p. 541 illus. in color.
3. Maguire JI, Federman JL. Intravenous fluorescein angiography. In: Tasman W, Jaeger EA, eds. Duane's Ophthalmology. 15th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2009:chap 44.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
- ClinicalTrials.gov ID
- NCT02478346
- Acronym / sponsor ID
- Fluoescein / 684812
- Conditions
- Cerebrovascular Disorders, Intracranial Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focuses on implementing Yellow 560 for the direct intraoperative visualization of Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop better treatment protocols, and improve the prognosis of a wide array of neurosurgical diseases. More specifically, for the patients who are undergoing surgical intervention for the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or in general residual lesion which must be corrected.
Detailed description
The research design is a prospective clinical study. All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). Surgery will continue with the aid of the Yellow 560 microscope with a minimum delay of 10 minutes after injection to reduce the amount of leakage of Fluorescein Sodium into the surrounding tissue.
Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
No other additional neurosurgical instruments will be used. Patients will be treated post-operatively with conventional adjunctive therapies and imaging as deemed necessary by the attending neurosurgeon for the evaluation of extent of surgery. Follow-up data (including post-operative images assessing outcomes and complications) will be collected on all patients on standard post-operative visits. Intra-operative films or recordings and all patient data may be saved and used according to HIPAA allowances.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Experimental | Drug: Fluorescein SodiumAll patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age ≥ 18)
- Diagnosed by preoperative imaging modalities to have a brain tumor (including metastatic brain tumors) or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.
- The patient is determined by a board certified neurosurgeon to have a tumor or vascular lesion that would take up fluorescein
- Patient or legally authorized representative provides written informed consent to enroll in this study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescein SodiumConventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography. | Drug | All Patients |
Primary outcome
Incidence of Intracerebral lesion
Time frame: Particpants will be followed from enrollment into study which include atleast to 2 images and any other image done up to 1 year of scheudled follow up.
The main outcome measure of the study would be a comparison between patient pre-operative and post-operative images to evaluate the potential utility of using Fluorescein Sodium and the Yellow 560 microscope to aid in the treatment of intracranial tumors and vascular lesions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Background1. Ciardella AP, Kaufman SR, Yannuzzi LA. The use of fluorescein angiography in acquired macular diseases. In: Tasman W, Jaeger EA, eds. Foundations of Clinical Ophthalmology. 15th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2009:chap 113F.
- Background2. Dithmar, Stefan, Holz, Frank G. Fluorescence Angiography in Ophthalmology. 2008, X, 224 p. 541 illus. in color.
- Background3. Maguire JI, Federman JL. Intravenous fluorescein angiography. In: Tasman W, Jaeger EA, eds. Duane's Ophthalmology. 15th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2009:chap 44.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Gandhi, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluorescein Sodium in people with Cerebrovascular Disorders and Intracranial Neoplasms, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cherlynn Basignani, BSN,RN,CCRC (407-303-3247, cherlynn.basignani@flhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intracerebral lesion (time frame: Particpants will be followed from enrollment into study which include atleast to 2 images and any other image done up to 1 year of scheudled follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02478346, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.